- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002253
A Multicenter Placebo-Controlled Double Blind Study to Evaluate the Efficacy and Safety of Sandostatin ( SMS 201-995 ) in Patients With Acquired Immunodeficiency Related Diarrhea Who Were Either "Responders" or "Non-Responders" in a Prior Placebo-Controlled Double-Blind Sandostatin Study.
The primary objective of this study is to determine the relapse rate in patients with AIDS-related diarrhea who were found to be "Responders" in a previous placebo-controlled, double-blind study of Sandostatin (Study #D203 - FDA 102A).
The secondary objectives include: 1) To evaluate clinical efficacy and safety of open-label Sandostatin in patients who were "Non-Responders" in Study #D203 - FDA 102A; 2) To evaluate the efficacy and safety of Sandostatin during prolonged open-label treatment in "Responders" from Study #D03 - FDA 102A.
Study Overview
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90033
- Usc School Of Medicine
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San Diego, California, United States, 92103
- UCSD Med Ctr
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San Francisco, California, United States, 94115
- Kaiser Permanente Med Ctr
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San Francisco, California, United States, 94110
- UCSF - San Francisco Gen Hosp
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San Mateo, California, United States, 94403
- San Mateo County Gen Hosp
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Florida
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Miami, Florida, United States, 33125
- Med Service
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Georgia
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Atlanta, Georgia, United States, 30303
- Emory Univ School of Medicine
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Illinois
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Chicago, Illinois, United States, 60612
- Rush Presbyterian - Saint Luke's Med Ctr
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Maine
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Portland, Maine, United States, 04102
- Maine Med Ctr Med Clinics
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Douglas Plesko
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Boston, Massachusetts, United States, 02118
- Boston City Hosp
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Hosp
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Missouri
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Kansas City, Missouri, United States, 64108
- Univ of Missouri at Kansas City School of Medicine
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New York
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New York, New York, United States, 10029
- Mount Sinai Med Ctr
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Stony Brook, New York, United States, 117948121
- SUNY Stony Brook / Health Sciences Ctr
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Oregon
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Portland, Oregon, United States, 97210
- Portland Veterans Adm Med Ctr / Rsch & Education Grp
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Buckley Braffman Stern Med Associates
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Rhode Island
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Providence, Rhode Island, United States, 02906
- Miriam Hosp / Family Healthcare Ctr at SSTAR
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Texas
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Galveston, Texas, United States, 77550
- Univ TX Galveston Med Branch
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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Virginia
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Annandale, Virginia, United States, 22203
- Infectious Disease Physicians Inc
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Wisconsin
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Madison, Wisconsin, United States, 53792
- Univ of Wisconsin School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Patients must have the following:
- Only patients who have completed the duration of Study D203, FDA 102A will be eligible for this study.
- Each of these patients must give written informed consent to participate in Study D204, FDA 102B as well.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: Double
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 102B
- D204
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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